Clinical Quality Assurance Auditor

at  Novocure

Location:Root D4, CH, 6039
Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer and other types of solid cancers.
To support our team in Root, Switzerland we are looking for a

YOUR PROFILE:

• Previous experience in Clinical Quality Assurance, Clinical experience in a Pharmaceutical setting, preferable in a medical device regulated environment
• Proven auditing experience
• Experience with Regulatory Inspections
• Working knowledge of ICH-E6(R2), ISO 14155:2020
• Excellent written and oral communications
• Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to change priorities
• Willingness to work in an international environment and travel around 60% of time (international and domestic)
  We are looking forward to receive your application to Natalia Kochanowicz, Senior Talent Acquisition Partner through our ApplicantPortal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.

• Conducts Audits to clinical vendors and investigational sites
• Coordinates the activities of Clinical Quality Co-Auditors
• Ensures that audit results are appropriately recorded, reported and communicated and that corrective/preventive actions are properly completed and documented in a timely manner.
• Follows-up on activities to address outcome of conducted audits until their resolution
• Manages and maintains databases for the Quality System
• Supports annual audit plan preparation with a risk-based approach
• Participates and supports different inspection activities (Pre-Approval/routine inspection preparation, inspection anticipation, support and host) and ensures their timely and consistent communication
• Leads and supports Quality improvement projects and initiatives
• Supports Internal Audit Activities as needed
• Evaluates / manages quality issues, CAPAs, and ensures their consistent escalation and communication.
• Prepares and presents the Quality Reviews and Lesson Learnt for the clinical projects based on the audits and inspections’ outcomes and issues and CAPAs, on a risk-based approach
• Supports training activities to increase Quality Awareness and Inspection Readiness in relation to clinical activities
• Ensures activities comply with the applicable Novocure Quality System requirements
• Ensures all duties and responsibilities are fulfilled in line with the established timelines.